Highlight

1. Superior MoA

The asset is a viscous gel formulation of TMZ in a biologically inert matrix developed for intracranial local administration. Current data shows that local TMZ administration offers superior TMZ availability at the tumor site, thereby enhancing tumor suppression compared to standard-of-care alone.

2. Superior Efficacy: Local injection increase TMZ concentration in the targeted brain tissue

1) In a mouse glioblastoma model, the asset reduces tumor size even before starting radiation therapy and systemic TMZ administration.

2) Local injection of the novel formulation dramatically enhances tumor growth inhibition compared to radiation + systemic TMZ by 34%.

3. Superior Safety: local injection limits unnecessary systemic exposure to TMZ

1) Gel formulation offers superior local concentration for tumor inhibition with decreased risk of systemic side effects.

2) TMZ plasma/brain ratios are only 0.1%-4% indicating retention of drug intracranially.

4. Proven safe and effective and already marketed in CIS region

1) Clinical trials completed in CIS region and registered as first-line treatment of glioblastoma.

2) Clinical trial data shows increased patient’s life for more than 9 months.